A Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared With Vehicle in Subjects With Fuchs Endothelial Corneal Dystrophy (FECD)
NCT ID: NCT05376176
Last Updated: 2025-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
86 participants
INTERVENTIONAL
2022-05-19
2025-05-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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STN1010904 ophthalmic suspension 0.03% BID
STN1010904 ophthalmic suspension 0.03% BID
0.03% STN1010904 ophthalmic suspension BID
STN1010904 ophthalmic suspension 0.1% BID
STN1010904 ophthalmic suspension 0.1% BID
0.1% STN1010904 ophthalmic suspension BID
Placebo Vehicle BID
Placebo (Vehicle) BID
Placebo (vehicle) BID
Interventions
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STN1010904 ophthalmic suspension 0.03% BID
0.03% STN1010904 ophthalmic suspension BID
STN1010904 ophthalmic suspension 0.1% BID
0.1% STN1010904 ophthalmic suspension BID
Placebo (Vehicle) BID
Placebo (vehicle) BID
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Any ocular surgery for FECD (e.g., penetrating keratoplasty (PKP), Descemet stripping endothelial keratoplasty (DSEK), Descemet membrane endothelial keratoplasty (DMEK), Descemet stripping automated endothelial keratoplasty (DSAEK), Descemet stripping only (DSO) in the study eye.
30 Years
75 Years
ALL
No
Sponsors
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ActualEyes Inc.
UNKNOWN
Santen Inc.
INDUSTRY
Responsible Party
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Locations
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Stein Eye Institution UCLA
Los Angeles, California, United States
Price Vision Group
Indianapolis, Indiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Tauber Eye Center
Kansas City, Missouri, United States
Comprehensive Eye Care, Ltd
Washington, Missouri, United States
Metropolitan Eye Research and Surgery Center
Palisades Park, New Jersey, United States
Devers Eye Institute
Portland, Oregon, United States
Scott Christie and Associates
Cranberry Township, Pennsylvania, United States
UPMC
Pittsburgh, Pennsylvania, United States
Houston Eye Associates
Houston, Texas, United States
Fondation Ophtalmologique Adolphe de Rothschild
Paris, , France
University Hospital of Saint-Etienne
Saint-Etienne, , France
Medical Research Foundation
Chennai, Tamil Nadu, India
Suven Clinical Research CenterL V Prasad Eye Institute
Banjara Hills, Telangana, India
Countries
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Other Identifiers
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101090401IN
Identifier Type: -
Identifier Source: org_study_id
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